Time-to-Detection in Culture of Mycobacterium Tuberculosis

Time-to-Detection in Culture of Mycobacterium Tuberculosis : Performance for Assessing Index Cases Infectivity

determination if time-to-detection in cultures of M. tuberculosis samples is more discriminating than acid-fast staining in transmission

Study Overview

• Status: Completed
• Conditions: Pulmonary Tuberculoses
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 705

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Nice University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 94 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all cases of pulmonary tuberculosis who had a sample analysed by the laboratory of bacteriology of Nice University Hospital, and that was positive in culture before treatment and of which contact cases were explored by the CLAT

Description

Inclusion Criteria:

• have at least 1 contact case explored for tuberculosis
• latent tuberculosis infection

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Index cases	Other: No intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tuberculosis transmission	duration of Tuberculosis transmission between an infected person and a contact case	2 months
contact case tracking	screening time for contact cases	2 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: 22Infectio01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No